Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Assembly Defect
Zimmer Biomet is recalling 638 Affixus Hip Fracture Nails because a manufacturing defect may prevent proper assembly of the device.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a functional defect that could prevent proper assembly, representing a risk of harm where injury has not yet been reported.
Plain-English summary
Zimmer Biomet, Inc. is recalling 638 units of the Affixus Hip Fracture Nail, LH 130 DEG 11MM X 400MM. The recall involves specific lots with expiration dates of May 29, 2027, and June 4, 2027. The product was distributed nationwide in the United States, as well as in Portugal and the Netherlands.
The recall was initiated because a defect was detected during a rework process for a previous field action. The set screw and sleeve assembly, which are designed to have an interference fit, were found to be no longer in the installed location. This defect could prevent the product assembly from working correctly with the mating screw and targeting jig.
Healthcare providers and facilities that have received these specific units should stop using them and contact Zimmer Biomet for instructions on how to return or replace the devices. Patients who have already had these devices implanted should consult their healthcare provider if they have concerns.
The recalled product
- Product
- Affixus Hip Fracture Nail, LH 130 DEG 11MM X 400MM
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
- Affected units
- 638
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Item No. 814611400
- 702230 (06/04/2027) UDI (01)00887868039836 (17)270604 (10)702230
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 65 recalled by Zimmer Biomet, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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